Cleared Traditional

K031091 - VTI 20 MHZ GATED DOPPLER
(FDA 510(k) Clearance)

K031091 · Vascular Technology Incorporated · Cardiovascular device

Apr 2003

Decision

16d

Days

Class 2

Risk

K031091 is an FDA 510(k) clearance for the VTI 20 MHZ GATED DOPPLER. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).

Submitted by Vascular Technology Incorporated (Lowell, US). The FDA issued a Cleared decision on April 23, 2003, 16 days after receiving the submission on April 7, 2003.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number	K031091 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 2003
Decision Date	April 23, 2003
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement